| CTRI Number |
CTRI/2023/08/056278 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different ways of intubating patients with cervical (neck) spine abnormality (difficult airway) |
|
Scientific Title of Study
|
Comparison of videolaryngoscopy and video-assisted fiberoptic intubation using C-MAC in patients with cervical spine abnormality |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rini E Francis |
| Designation |
Junior Resident, Department of Anaesthesia |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology , Kasturba Medical College, Manipal Academy of Higher Education, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7994363874 |
| Fax |
|
| Email |
rinivareed@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaji Mathew |
| Designation |
Professor of Anaesthesia |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesia, Kasturba Medical College, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9449388791 |
| Fax |
|
| Email |
shajimanipal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaji Mathew |
| Designation |
Professor of Anaesthesia |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesia, Kasturba Medical College, Manipal - 576104
KARNATAKA
576104
India |
| Phone |
9449388791 |
| Fax |
|
| Email |
shajimanipal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Tiger Circle Road, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka- 576104 |
|
|
Primary Sponsor
|
| Name |
Rini E Francis |
| Address |
Department of Anaesthesia, Kasturba Medical College, Manipal |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rini E Francis |
Kasturba Medical College |
OT Complex, Department of Anaesthesia, Kasturba Medical College, MAHE (Manipal Academy of Higher Education), Tiger Circle Road, Madhav Nagar, Manipal, Udupi, Karnataka(576104)
Udupi
KARNATAKA |
7994363874
rinivareed@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
combined use of C-MAC video-laryngoscope and fiberoptic bronchoscope for intubation |
combined use of C-MAC video-laryngoscope and fiberoptic bronchoscope for intubation in patients with cervical spine abnormality |
| Comparator Agent |
use of videolaryngoscope for intubation |
use of C-MAC Video-laryngoscope with stylet for intubation in patients with cervical spine abnormality |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients in age group of 18-65 years of age of ASA status 1,2 with cervical spine abnormality planned for surgery |
|
| ExclusionCriteria |
| Details |
Patients of ASA physical status 3,4 and 5.
Patients planned for awake fiberoptic intubation.
Patients planned for nasal intubation.
Patients with restricted mouth opening. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt intubation success (tracheal tube placed and correct positioning confirmed by capnogram with a single manoeuvre) |
within 30 seconds of placing video-laryngoscope |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
time to intubate
number of attempts required to intubate
any need for alternative airway devices or methods of intubation
vitals( heart rate, blood pressure, oxygen saturation) before & at the time of intubation
incidence of airway injuries(bleeding, injury to lips, gums, teeth, pharnx & larynx) |
time to intubate(from insertion of video-laryngoscope to the appearance of end-tidal carbon di-oxide waveform)- within 30 seconds of placing video-laryngoscope.
need for alternative airway devices or methods of intubation- Yes or No
Heart rate in beats per minute, blood pressure in mmHg & oxygen saturation in percentage (5 minutes before intubation & at the time of intubation). Incidence of airway injury-present/absent (during video-laryngoscope insertion & during intubation) |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized , open label, parallel arm , prospective interventional single centre trial comparing video-laryngoscopy and video-assisted fiberoptic intubation in patients with simulated cervical spine abnormality. Primary outcome is measured by first attempt intubation success. Secondary outcome is measured by time taken to intubate, number of attempts required, any need for alternative airway devices or methods of intubation, vitals( heart rate, blood pressure and oxygen saturation level in blood) |